Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT02189135
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2014-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Making Ramadhan Fasting a Safer Experience With Technology Study
Sponsor:
Monash University
Organization:
Study Overview
Official Title:
Making Ramadhan Fasting a Safer Experience With Technology Study
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of illness, disability, and death in Malaysia with an increasing prevalence. Despite the best effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2 diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will generally consume large quantities of fried and sugary foods when they break their fast or during the night. Given the importance and public health significance of poor diabetes management and its associated risk especially during Ramadan, the investigators aim to test the intervention of using remote monitoring within community provider practice for patients with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer which can directly feedback the patients glycaemic levels to the physicians will reduce and even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain euglycaemic throughout the whole Ramadan month.
Detailed Description:
Eligible participants will be assigned based upon their participating site. Treatment assignments are unmasked. Intervention group will utilize a web enabled glucometer manufactured by Entra Health System (San Diego, California). The glucometer acts by automatically uploading any glucose readings to an online portal currently managed by Entra Health System. The web portal would host the patient's raw blood glucose in a logbook form and laboratory data. A summary of the patient's gylcaemic and metabolic control (lipid, blood pressure, weight) control, self-management skills as well as compliance to other key measures such as eye examination, screening for microvascular complications would also be provided if available. All patients in this intervention arm would be given a system-driven guidance on when to test their blood glucose based on their disease status, medication regimen, and time of poorest control so that the most useful, patient specific blood profile can be created and used for future self-management coaching for patient.
In the event that there is 3 continuous readings of hypoglycaemia (3.9mmol/L and below) or hyperglycaemia (11.1mmol/L and above), the system will automatically generate a message to inform the attending physician. The physician then has an option to use this information, but will remain responsible for all treatment decisions. For quality assurance, the physicians will be required to periodically review the participant's electronic logbook data and summary analysis reports, generated for patients and physicians. These feedbacks will be entered into an electronic logbook and captured real-time. A report will be generated summarizing the self-management actions for improving their diabetes control will be sent to the patients, physicians as well as family member every month. Each patient will also be informed that action plan serves as a pre-visit summary for the patient's next visit to their physician. In addition, the participant's family member(s) will also be invited to participate and if consented updated on the status of the participants blood glucose status periodically and be prompted whenever their glycaemic levels are beyond the target.
Participants assigned to the control group will continue to receive their usual medical care as they would from their physician or general practitioner including checking patient self-management blood glucose and log books. In addition, participants will receive standard lifestyle advice and will be given basic information on diabetes prevention, weight loss, diet, and exercise consistent with expert recommendation for a healthy lifestyle. Participants will also receive a glucose meter and supplies for 3 months. Participants will be told to use the glucose meter as recommended by their physicians. Control participants will also receive publically available literatures such as flyers and brochures.
In the event that there is 3 continuous readings of hypoglycaemia (3.9mmol/L and below) or hyperglycaemia (11.1mmol/L and above), the system will automatically generate a message to inform the attending physician. The physician then has an option to use this information, but will remain responsible for all treatment decisions. For quality assurance, the physicians will be required to periodically review the participant's electronic logbook data and summary analysis reports, generated for patients and physicians. These feedbacks will be entered into an electronic logbook and captured real-time. A report will be generated summarizing the self-management actions for improving their diabetes control will be sent to the patients, physicians as well as family member every month. Each patient will also be informed that action plan serves as a pre-visit summary for the patient's next visit to their physician. In addition, the participant's family member(s) will also be invited to participate and if consented updated on the status of the participants blood glucose status periodically and be prompted whenever their glycaemic levels are beyond the target.
Participants assigned to the control group will continue to receive their usual medical care as they would from their physician or general practitioner including checking patient self-management blood glucose and log books. In addition, participants will receive standard lifestyle advice and will be given basic information on diabetes prevention, weight loss, diet, and exercise consistent with expert recommendation for a healthy lifestyle. Participants will also receive a glucose meter and supplies for 3 months. Participants will be told to use the glucose meter as recommended by their physicians. Control participants will also receive publically available literatures such as flyers and brochures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: